MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Spasm(s) (1966); Seizures (2063); No Code Available (3191)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient and her sister reported that she was having the shakes and reported some recent seizures.They stated that the neurologist didn't know what was wrong.The sister then reported that the patient¿s vns neck site was swollen, and you could clearly see where the vns was.She said that you could see the vns stimulation vibrating in the neck.No further relevant information has been received to date.

Event Description

The physician reported that at the last visit the patient reported tremors and worsening seizures for which the patient was hospitalized and the patient medications were updated.The patient was referred for assessment to see if her tremors were due to parkinsons disease.The physicians office indicated that the increased seizures and tremors appeared to be related to disease progression/other factors not the vns.There was no concern of any problems with the vns at the time of the appointment.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10796559
• MDR Text Key: 215612502
• Report Number: 1644487-2020-01482
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/11/2019
• Device Model Number: 106
• Device Lot Number: 204051
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR